Rate of non-prescription pain medication use [ Designated as safety issue: No ]

Rate of opioid use [ Designated as safety issue: No ]

Rate of other pain therapy use [ Designated as safety issue: No ]

Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores [ Designated as safety issue: No ]

Relationship between genetic biomarkers and the worst pain score [ Designated as safety issue: No ]

Differences between the results seen in the majority Caucasian population and the minority population (as a whole and broken down into Hispanic vs Black vs Asian vs Native American vs Pacific Islander) [ Designated as safety issue: No ]

Correlation of baseline pain, baseline analgesic intake, or baseline neuropathy symptoms with the eventual development of paclitaxel-associated acute pain syndrome or neuropathy [ Designated as safety issue: No ]

Estimated Enrollment:

360

Study Start Date:

February 2009

Estimated Primary Completion Date:

April 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To describe the incidence and characteristics of and change in pain related to paclitaxel infusions over several courses in patients receiving paclitaxel weekly or every 2-4 weeks with or without neurotoxic chemotherapy.

To perform a genotype-phenotype correlation study to identify genetic biomarkers that may contribute to the variation observed in paclitaxel-related toxicity using top candidate single nucleotide polymorphisms (SNPs) from a genome-wide SNP association study of 300 human lymphoblastoid cell lines.

To explore whether there are any evident differences between results seen in the majority Caucasian population and the minority populations.

OUTLINE: This is a multicenter study. Patients are grouped according to paclitaxel dosing schedule (weekly vs every 2-4 weeks) and concurrent use of neurotoxic agent (yes vs no).

Group I: Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

Group II (closed to accrual as of 12/4/2009): Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

Group III (closed to accrual for general population, but remains open to minority accrual only as of 8/7/2009): Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

Group IV: Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

Blood samples are collected at baseline for correlative laboratory studies, including genetic biomarker and polymorphism studies.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Diagnosis of cancer

Planning to receive paclitaxel IV (excluding paclitaxel albumin-stabilized nanoparticle formulation [nab-paclitaxel]) according to one of the following dosing schedules:

No prior or concurrent peripheral neuropathy (from diabetes or other causes)

No prior or concurrent fibromyalgia

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

No prior paclitaxel or neurotoxic chemotherapy drugs, including other taxanes, platinum agents, vinca alkaloids, or epothilones

No concurrent neutrophil colony-stimulating factor therapy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860041